Analyst, QC Micro – Lab

Resilience; Port Union (OH); On-site; USD 33,000 - 48,000; Full time

Job summary

Resilience, a biomanufacturing company in the United States, is seeking an Analyst, QC Micro to perform microbiological testing and support the site’s control program in Ohio. The role involves routine sampling, autoclaving, in-process testing, and maintaining clean, compliant records in a cGMP environment.

You will write and revise SOPs, analyze data trends, and contribute to CAPA and process improvements.

Qualifications

• Experience performing microbiological testing in a regulated or cGMP lab.
• Ability to analyze data trends and identify deviations.
• Strong documentation and record-keeping in line with GMP.
• Experience writing and revising SOPs and work instructions.

Responsibilities

• Perform routine sampling, testing, autoclaving, and parts washing per cGMP.
• Maintain accurate records and logs; ensure quality documentation.
• Audit SOPs and support regulatory inspections.
• Train others on systems, procedures, and SOPs.
• Interact with cross-functional teams to drive CAPA and improvements.

Skills

Microbiology testing

cGMP compliance

Data analysis

Documentation

SOP development

Education

Bachelor’s degree in biology, microbiology, or related discipline

Tools

MS Office

Laboratory instrumentation

Job description

A career at Resilience is more than just a job – it’s an opportunity to change the future.Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.For more information, please visit www.resilience.comBrief Job DescriptionThe Analyst, QC Micro – Lab performs microbiological testing and quality control activities in support of the site’s microbiological control program.Job ResponsibilitiesCore ResponsibilitiesPerform routine sampling, utility testing, in-process testing, autoclaving, and parts washing in accordance with cGMPPerform visual inspections and verify materials for correct components, quantities, and characteristicsMonitor equipment and systems for performance and problem indicators; troubleshoot and implement temporary and permanent fixesMaintain accurate records and archived documentation (laboratory notebooks, logbooks, quality records, sample receipts) per good documentation practices, including periodic logbook reviewsWrite, review, and revise SOPs and work instructions for cGMP manufacturing, equipment, systems, and facilitiesAnalyze data trends to identify root causes, collect and report quality metrics, and recommend corrective actionsAudit SOPs and work instructions to ensure compliance with regulatory requirements; escalate issues outside of SOPs to supervisor or managerInteract with regulatory agency personnel during audits and inspectionsContribute to compliance, CAPA, and process improvement activitiesTrain others on systems, equipment, procedures, and SOPsServe as an SME cross-functionally; answer compliance and process questions and coordinate with support groupsCommunicate policies, procedures, and operational information across employee and management levelsUse CMMS to manage logisticsExperience & EducationMinimum QualificationsExperience performing microbiological testing or analytical laboratory work in a regulated or cGMP environmentAbility to independently apply laboratory skills within own job area, drawing on microbiological knowledge and cGMP experienceAbility to analyze laboratory data, identify trends or deviations, and escalate observations and recommendations to supervisorWorking knowledge of cGMP documentation requirements (logbook practices, deviation identification, SOP compliance)Ability to prepare clear, accurate technical documentation consistent with cGMP requirementsPreferred QualificationsBachelor’s degree in biology, microbiology, or a related discipline1+ years of experience in a regulated or cGMP laboratory environmentProficiency with laboratory instrumentationWorking knowledge of cGXP requirements and familiarity with production operationsProficiency with MS Word and Microsoft Office applicationsKnowledge of cGMPs and FDA regulationsPhysical & Work EnvironmentThis is primarily a non-sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP.Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.Using a computer keyboard, mouse, or other electronic/laboratory device; interpreting sounds and associated meanings at volume levels consistent with interpersonal or group conversations; interpreting letters and numbers when viewed on a computer screen, monitor, reports and other documents; identifying and distinguishing colors.All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.Work Schedule: Monday - Friday with some on - call supportThe work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. This role requires the ability to provide 24/7 on-call support as needed.Sponsorship or support for work authorization, including visas, is not available for this position.Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $24.00 - $34.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.